Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

Overview

This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.

Full Title of Study: “A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole 15 mg and Antacid Versus Lansoprazole 15 mg and Antacid (Calcium Carbonate and Magnesium Hydroxide) Alone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
    • Tablet
  • Drug: Lansoprazole
    • Tablet
  • Drug: Calcium carbonate/magnesium hydroxide
    • Tablet
  • Drug: Placebo
    • Tablet

Arms, Groups and Cohorts

  • Experimental: Combination product
    • Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
  • Active Comparator: PPI alone
    • Lansoprazole
  • Active Comparator: Antacid alone
    • Calcium carbonate/magnesium hydroxide
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
    • Time Frame: 1 day
    • Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.

Secondary Measures

  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
    • Time Frame: 1 day
    • Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long. 0 millimeters: None (no heartburn) 100 millimeters: Most severe
  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
    • Time Frame: 1 day
    • Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long. 0 millimeters: None (no heartburn) 100 millimeters: Most severe
  • Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
    • Time Frame: 1 day

Participating in This Clinical Trial

Inclusion Criteria

  • Experiencing heartburn in the past month if untreated – Having heartburn that responds to heartburn medication – Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. Exclusion Criteria:

  • Having history of erosive esophagitis or gastroesophageal reflux disease (GERD) diagnosed by a physician and confirmed by testing (endoscopy) – Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study. "Other protocol-defined inclusion/exclusion criteria may apply"

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Head, New Therapeutic Opportunities, Novartis
  • Overall Official(s)
    • Novartis ., Study Director, Novartis

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